Calibration of Friability Test Apparatus : Pharmaceutical Guidelines

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Calibration of Friability Test Apparatus

Learn how to calibrate the Friability Test Apparatus used to test the friability of tablets.
1. Switch ON the power.
2. Drum will initialize itself to the loading position at the power ON.
3. Display will show Start.
4. After weighing (A) Slide the tablets (For tablets with a unit mass equal to or less than 650 mg, take a sample of whole tablets corresponding to 6.5 g. For
tablets with a unit mass of more than 650 mg, take a sample of whole 10 tablets) gently into the drum from the side slit provided on the drum.
5. Select the TIME MODE or REVOLUTION COUNT MODE as desired by pressing the TIME/COUNT key respectively.
6. The MODE indicator LED will indicate the selected mode.
7. Display will show the previous Time or Count Values.
8. Enter the desired value (25 rpm, 4 minutes or described under individual monograph) for the selected mode and press ENTER key to register the value.
9. Press RUN/HALT key to start the test.
10. Drum will start rotating.
11. Display will show elapsed Time or Count on depending on the mode selected.
12. When the test is over, the drum rotates in the reverse direction, discharging the tablets into the tray. Take weight after rotation is completed (B). Then
drum oscillates gently to make sure that all tablets are discharged into the tray. The test over is indicated by an audible keep and the display would show
END.
13. The drum will initialize itself to loading position and display will show Start indicating that the instrument is ready for the next test.
14. Incase during the test, if the user needs to change the Time/Count Value, Press RUN/HALT key. The instrument is now in HALT state. The blinking of the
selected Mode Led (Either TIME or COUNT LED) on the front panel indicates that HALT State of the instrument if the value fed is below the elapsed Time or
Count then the instrument would prompt Err on the display.
15. Pressing the RUN/HALT key again to continue the test.
16. Find out the loss in weight of the tablets (i.e. A B).
17. Calculate the percentage of loss by following formulae
(A - B) X 100
A
18. Find out the percentage loss.
19. Make entry in the usage log book
20. Similarly operate the instrument and count the revolution for calibration as per Annexure-I
21. Calibration frequency: Monthly and after major maintenance.
22. Affix the calibration label.
Related:SOP for Cleaning of Friability Test Apparatus

Annexure-I
Sr.
Parameter
Standard Value
Observed value
No.
Revolutions
Time
1
50 revolutions/2
2 minutes
minutes
100 revolutions/4
4 Minutes
2
Count
minutes
3
150 revolutions/6
6 minutes
minutes

Limits

Remarks

49 51
98 - 102
147 - 153

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical
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12/23/2016 7:42 PM